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Completed

NCT Number: NCT00924768

A Study of Inhalation of 20,000 EU CCRE and Mucociliary Clearance (MCC) in Otherwise Healthy Individuals Who Are Current Cigarette Smokers

The purpose of this Phase 1 research study is to identify a dose of inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other problems), but causes changes in sputum cell samples that the scientists can measure. The investigators are also interested in seeing if the exposure to the endotoxin decreases the body's natural ability to clear mucus from the lungs.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599, United States

About this study

The purpose of this study is to determine the range of neutrophil response (influx of PMNs to the airways as determined in sputum) after inhalation of CCRE (20,000 EU), shown in previous studies of healthy, nonsmoking volunteers as well as in a limited number of otherwise healthy smokers to be well tolerated. This dose induces measurable increases in neutrophil content of induced sputum that can be employed to screen large populations for susceptibility to the inflammatory effect of inhaled endotoxin. Limitations of the understanding of actions of inflammatory stimuli on airway function are likely due to the fact that functional assessments of dynamic airway response /in vivo/ have generally been limited to those based on spirometry and examination of airway samples for assessment of cells and mediator content. Slowing of mucociliary clearance (MCC), a key component of airway defense, can be induced by inflammation and almost certainly contribute to mucus plugging and decreased clearance of inhaled irritants. Measures of mucociliary clearance (MCC), by inhalation of radiolabeled particles to label airway surface liquid, suggest that clearance of secretions is impaired to a mild degree in smokers and more severely in patients hospitalized for acute exacerbations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be current cigarette smokers
  • Must be otherwise healthy
  • Must be good sputum producers

Exclusion criteria

  • Any acute illness any chronic illness which would impact results

Treatment and study plan

20K EU CCRE

Biological

Inhalation of CCRE

Primary outcomes

  1. Increase in sputum neutrophils

    Time frame: 6 hours

Secondary outcomes

  1. Mucociliary clearance rates

    Time frame: 4 hours

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

A Study of Inhalation of 20,000 EU CCRE and MCC in Otherwise Healthy Individuals Who Are Current Cigarette Smokers

Acronym: IRB 09-0259

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 19, 2009
Registry last updated
Aug 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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